Trial Outcomes & Findings for A Mechanistic Study of GSK3228836 With Fine Needle Aspiration (FNA) in Participants With Chronic Hepatitis B (NCT NCT04544956)
NCT ID: NCT04544956
Last Updated: 2025-07-15
Results Overview
Percentage of participants achieving serum HBsAg level \<LLOQ were reported. Percentage values are rounded-off.
COMPLETED
PHASE2
12 participants
Up to Week 12
2025-07-15
Participant Flow
This was an open label, single arm study to mechanistically interrogate the therapeutic effect of GSK3228836 in participants with Chronic Hepatitis B via intrahepatic immunophenotyping.
A total of 12 participants were enrolled in this study.
Participant milestones
| Measure |
GSK3228836 300 mg
Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) administered subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
GSK3228836 300 mg
Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) administered subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Mechanistic Study of GSK3228836 With Fine Needle Aspiration (FNA) in Participants With Chronic Hepatitis B
Baseline characteristics by cohort
| Measure |
GSK3228836 300 mg
n=12 Participants
Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) administered subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).
|
|---|---|
|
Age, Continuous
|
48.8 Years
STANDARD_DEVIATION 8.48 • n=5 Participants
|
|
Sex/Gender, Customized
De-identified
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
De-identified
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Week 12Population: Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment.
Percentage of participants achieving serum HBsAg level \<LLOQ were reported. Percentage values are rounded-off.
Outcome measures
| Measure |
GSK3228836 300 mg
n=12 Participants
Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) administered subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).
|
|---|---|
|
Percentage of Participants Achieving Serum Hepatitis B Virus Surface Antigen (HBsAg) Level Less Than (<) Lower Limit of Quantitation (LLOQ)
|
25 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 weeks off treatment (Study Weeks 12 to 36)Population: Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment.
Sustained HBsAg response is defined as HBsAg \<LLOQ for 24 weeks from end of GSK3228836 treatment. Percentage values are rounded-off.
Outcome measures
| Measure |
GSK3228836 300 mg
n=12 Participants
Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) administered subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).
|
|---|---|
|
Percentage of Participants With Sustained HBsAg Response (HBsAg <LLOQ) for 24 Weeks After the Planned and Actual End of GSK3228836 Treatment
Sustained HBsAg Response for 24 Weeks after Planned End of GSK3228836 Treatment
|
8 Percentage of participants
|
|
Percentage of Participants With Sustained HBsAg Response (HBsAg <LLOQ) for 24 Weeks After the Planned and Actual End of GSK3228836 Treatment
Sustained HBsAg Response for 24 Weeks after Actual End of GSK3228836 Treatment
|
8 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 weeks off treatment (Study Weeks 12 to 36)Population: Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment.
Sustained virologic response is defined as HBsAg \<LLOQ and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \<LLOQ for 24 weeks from end of GSK3228836 treatment. Percentage values are rounded-off.
Outcome measures
| Measure |
GSK3228836 300 mg
n=12 Participants
Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) administered subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).
|
|---|---|
|
Percentage of Participants Achieving Sustained Virologic Response (HBsAg <LLOQ and HBV DNA <LLOQ) for 24 Weeks After the Planned and Actual End of GSK3228836 Treatment
Sustained Virologic Response for 24 Weeks after Planned End of GSK3228836 Treatment
|
8 Percentage of participants
|
|
Percentage of Participants Achieving Sustained Virologic Response (HBsAg <LLOQ and HBV DNA <LLOQ) for 24 Weeks After the Planned and Actual End of GSK3228836 Treatment
Sustained Virologic Response for 24 Weeks after Actual End of GSK3228836 Treatment
|
8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week -1), treatment Day 78 and off treatment (OT) Day 162Population: Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Percentage of participants achieving HBsAg \<LLOQ were assessed at indicated time points. Percentage values are rounded-off.
Outcome measures
| Measure |
GSK3228836 300 mg
n=12 Participants
Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) administered subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).
|
|---|---|
|
Percentage of Participants Achieving HBsAg <LLOQ at Indicated Time Points
Baseline (Week -1)
|
0 Percentage of participants
|
|
Percentage of Participants Achieving HBsAg <LLOQ at Indicated Time Points
Treatment Day 78
|
30 Percentage of participants
|
|
Percentage of Participants Achieving HBsAg <LLOQ at Indicated Time Points
Off Treatment Day 162
|
18 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week -1), treatment Day 78 and off treatment Day 162Population: Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Percentage of participants achieving HBV DNA \<LLOQ were assessed at indicated time points. Percentage values are rounded-off.
Outcome measures
| Measure |
GSK3228836 300 mg
n=12 Participants
Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) administered subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).
|
|---|---|
|
Percentage of Participants Achieving HBV DNA <LLOQ at Indicated Time Points
Baseline (Week -1)
|
92 Percentage of participants
|
|
Percentage of Participants Achieving HBV DNA <LLOQ at Indicated Time Points
Treatment Day 78
|
78 Percentage of participants
|
|
Percentage of Participants Achieving HBV DNA <LLOQ at Indicated Time Points
Off Treatment Day 162
|
100 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week -1), treatment Day 78 and off treatment Day 162Population: Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Percentage of participants achieving HBsAg \<LLOQ and HBV DNA \<LLOQ were assessed at indicated time points. Percentage values are rounded-off.
Outcome measures
| Measure |
GSK3228836 300 mg
n=12 Participants
Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) administered subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).
|
|---|---|
|
Percentage of Participants Achieving HBsAg <LLOQ and HBV DNA <LLOQ at Indicated Time Points
Baseline (Week -1)
|
0 Percentage of participants
|
|
Percentage of Participants Achieving HBsAg <LLOQ and HBV DNA <LLOQ at Indicated Time Points
Treatment Day 78
|
20 Percentage of participants
|
|
Percentage of Participants Achieving HBsAg <LLOQ and HBV DNA <LLOQ at Indicated Time Points
Off Treatment Day 162
|
18 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week -1), Treatment Week 12 and off treatment Week 24Population: Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Participants who achieved a decline in HBsAg values from Baseline were reported. Participants were categorized in the following categorical HBsAg decline of \<0.5, greater than or equal to (\>=) 0.5, \>=1, \>=1.5, and \>=3 log10 international units per milliliter (IU/mL). The 'HBsAg \< LLOQ' category is derived based on Absolute/raw HBsAg result. The HBsAg decline categories are based on change from Baseline values. Percentage values are rounded-off.
Outcome measures
| Measure |
GSK3228836 300 mg
n=11 Participants
Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) administered subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).
|
|---|---|
|
Percentage of Participants With Categorical Change From Baseline in HBsAg Values at Indicated Time Points
Treatment Week 12, HBsAg < LLOQ
|
30 Percentage of participants
|
|
Percentage of Participants With Categorical Change From Baseline in HBsAg Values at Indicated Time Points
Treatment Week 12, HBsAg decline <0.5 log10 IU/mL
|
10 Percentage of participants
|
|
Percentage of Participants With Categorical Change From Baseline in HBsAg Values at Indicated Time Points
Treatment Week 12, HBsAg decline >=0.5 log10 IU/mL
|
90 Percentage of participants
|
|
Percentage of Participants With Categorical Change From Baseline in HBsAg Values at Indicated Time Points
Treatment Week 12, HBsAg decline >=1 log10 IU/mL
|
80 Percentage of participants
|
|
Percentage of Participants With Categorical Change From Baseline in HBsAg Values at Indicated Time Points
Treatment Week 12, HBsAg decline >=1.5 log10 IU/mL
|
80 Percentage of participants
|
|
Percentage of Participants With Categorical Change From Baseline in HBsAg Values at Indicated Time Points
Treatment Week 12, HBsAg decline >=3 log10 IU/mL
|
50 Percentage of participants
|
|
Percentage of Participants With Categorical Change From Baseline in HBsAg Values at Indicated Time Points
Off Treatment Week 24, HBsAg < LLOQ
|
18 Percentage of participants
|
|
Percentage of Participants With Categorical Change From Baseline in HBsAg Values at Indicated Time Points
Off Treatment Week 24, HBsAg decline <0.5 log10 IU/mL
|
73 Percentage of participants
|
|
Percentage of Participants With Categorical Change From Baseline in HBsAg Values at Indicated Time Points
Off Treatment Week 24, HBsAg decline >=0.5 log10 IU/mL
|
27 Percentage of participants
|
|
Percentage of Participants With Categorical Change From Baseline in HBsAg Values at Indicated Time Points
Off Treatment Week 24, HBsAg decline >=1 log10 IU/mL
|
27 Percentage of participants
|
|
Percentage of Participants With Categorical Change From Baseline in HBsAg Values at Indicated Time Points
Off Treatment Week 24, HBsAg decline >=1.5 log10 IU/mL
|
27 Percentage of participants
|
|
Percentage of Participants With Categorical Change From Baseline in HBsAg Values at Indicated Time Points
Off Treatment Week 24, HBsAg decline >=3 log10 IU/mL
|
18 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week -1), treatment Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; off treatment Days 1, 8, 22, 50, 78, 106, 134 and 162Population: Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. The "n" represents the number of participants with Baseline ALT \> ULN and ALT data at that visit. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points to assess ALT levels. The ALT normalization (ALT \<=upper limit of normal \[ULN\]) over time in absence of rescue medication in participants with Baseline ALT\>ULN and ALT data at that visit. Participants who achieved ALT normalization were reported.
Outcome measures
| Measure |
GSK3228836 300 mg
n=12 Participants
Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) administered subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).
|
|---|---|
|
Number of Participants With Alanine Aminotransferase (ALT) Greater Than (>)3 Times Upper Limit of Normal (ULN) at Indicated Time Points
Baseline (Week -1)
|
0 Participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Greater Than (>)3 Times Upper Limit of Normal (ULN) at Indicated Time Points
Treatment Day 8
|
0 Participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Greater Than (>)3 Times Upper Limit of Normal (ULN) at Indicated Time Points
Treatment Day 15
|
0 Participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Greater Than (>)3 Times Upper Limit of Normal (ULN) at Indicated Time Points
Treatment Day 22
|
0 Participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Greater Than (>)3 Times Upper Limit of Normal (ULN) at Indicated Time Points
Treatment Day 29
|
0 Participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Greater Than (>)3 Times Upper Limit of Normal (ULN) at Indicated Time Points
Treatment Day 36
|
1 Participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Greater Than (>)3 Times Upper Limit of Normal (ULN) at Indicated Time Points
Treatment Day 43
|
1 Participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Greater Than (>)3 Times Upper Limit of Normal (ULN) at Indicated Time Points
Treatment Day 50
|
1 Participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Greater Than (>)3 Times Upper Limit of Normal (ULN) at Indicated Time Points
Treatment Day 57
|
1 Participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Greater Than (>)3 Times Upper Limit of Normal (ULN) at Indicated Time Points
Treatment Day 64
|
1 Participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Greater Than (>)3 Times Upper Limit of Normal (ULN) at Indicated Time Points
Treatment Day 71
|
1 Participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Greater Than (>)3 Times Upper Limit of Normal (ULN) at Indicated Time Points
Treatment Day 78
|
0 Participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Greater Than (>)3 Times Upper Limit of Normal (ULN) at Indicated Time Points
Off Treatment Day 1
|
0 Participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Greater Than (>)3 Times Upper Limit of Normal (ULN) at Indicated Time Points
Off Treatment Day 8
|
0 Participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Greater Than (>)3 Times Upper Limit of Normal (ULN) at Indicated Time Points
Off Treatment Day 22
|
0 Participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Greater Than (>)3 Times Upper Limit of Normal (ULN) at Indicated Time Points
Off Treatment Day 50
|
0 Participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Greater Than (>)3 Times Upper Limit of Normal (ULN) at Indicated Time Points
Off Treatment Day 78
|
0 Participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Greater Than (>)3 Times Upper Limit of Normal (ULN) at Indicated Time Points
Off Treatment Day 106
|
1 Participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Greater Than (>)3 Times Upper Limit of Normal (ULN) at Indicated Time Points
Off Treatment Day 134
|
0 Participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Greater Than (>)3 Times Upper Limit of Normal (ULN) at Indicated Time Points
Off Treatment Day 162
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week -1), treatment Days 29, 36, and 57; off treatment Days 1, 8, 22, 50, 78, 106, 134 and 162Population: Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected to assess HBe antibody levels and results reported are for Baseline HBeAg positive participants.
Outcome measures
| Measure |
GSK3228836 300 mg
n=12 Participants
Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) administered subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).
|
|---|---|
|
Number of Participants With HBe Antibody (Anti-HBeAg) Levels
Off Treatment Day 106
|
10 Participants
|
|
Number of Participants With HBe Antibody (Anti-HBeAg) Levels
Baseline (Week -1)
|
11 Participants
|
|
Number of Participants With HBe Antibody (Anti-HBeAg) Levels
Treatment Day 29
|
11 Participants
|
|
Number of Participants With HBe Antibody (Anti-HBeAg) Levels
Treatment Day 36
|
0 Participants
|
|
Number of Participants With HBe Antibody (Anti-HBeAg) Levels
Treatment Day 57
|
9 Participants
|
|
Number of Participants With HBe Antibody (Anti-HBeAg) Levels
Off Treatment Day 1
|
9 Participants
|
|
Number of Participants With HBe Antibody (Anti-HBeAg) Levels
Off Treatment Day 8
|
10 Participants
|
|
Number of Participants With HBe Antibody (Anti-HBeAg) Levels
Off Treatment Day 22
|
10 Participants
|
|
Number of Participants With HBe Antibody (Anti-HBeAg) Levels
Off Treatment Day 50
|
10 Participants
|
|
Number of Participants With HBe Antibody (Anti-HBeAg) Levels
Off Treatment Day 78
|
10 Participants
|
|
Number of Participants With HBe Antibody (Anti-HBeAg) Levels
Off Treatment Day 134
|
8 Participants
|
|
Number of Participants With HBe Antibody (Anti-HBeAg) Levels
Off Treatment Day 162
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week -1), treatment Day 78 and off treatment Day 162Population: Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected from participants at indicated time points to assess HBsAg levels.
Outcome measures
| Measure |
GSK3228836 300 mg
n=12 Participants
Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) administered subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).
|
|---|---|
|
Actual Values of HBsAg at Indicated Time Points
Baseline (Week -1)
|
3.29 Log10 IU/mL
Standard Deviation 0.590
|
|
Actual Values of HBsAg at Indicated Time Points
Treatment Day 78
|
0.33 Log10 IU/mL
Standard Deviation 1.432
|
|
Actual Values of HBsAg at Indicated Time Points
Off Treatment Day 162
|
2.08 Log10 IU/mL
Standard Deviation 1.933
|
SECONDARY outcome
Timeframe: Baseline (Week -1), treatment Day 78 and off treatment Day 162Population: Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. Participants who had Baseline and at least 1 post-Baseline visit values were included in analysis.
Blood samples were collected from participants at indicated time points to assess HBsAg levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
GSK3228836 300 mg
n=11 Participants
Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) administered subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).
|
|---|---|
|
Mean Change From Baseline in HBsAg at Indicated Time Points
Treatment Day 78
|
-2.923 Log10 IU/mL
Standard Deviation 1.5803
|
|
Mean Change From Baseline in HBsAg at Indicated Time Points
Off Treatment Day 162
|
-1.183 Log10 IU/mL
Standard Deviation 1.8343
|
SECONDARY outcome
Timeframe: Baseline (Week -1), treatment Day 78 and off treatment Day 162Population: Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected from participants at indicated time points to assess HBV DNA levels.
Outcome measures
| Measure |
GSK3228836 300 mg
n=12 Participants
Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) administered subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).
|
|---|---|
|
Actual Values of HBV DNA at Indicated Time Points
Baseline (Week -1)
|
0.43 Log10 IU/mL
Standard Deviation 0.849
|
|
Actual Values of HBV DNA at Indicated Time Points
Treatment Day 78
|
0.31 Log10 IU/mL
Standard Deviation 0.611
|
|
Actual Values of HBV DNA at Indicated Time Points
Off Treatment Day 162
|
0.24 Log10 IU/mL
Standard Deviation 0.525
|
SECONDARY outcome
Timeframe: Baseline (Week -1), treatment Day 78 and off treatment Day 162Population: Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. Participants who had Baseline and at least 1 post-Baseline visit values were included in analysis.
Blood samples were collected from participants at indicated time points to assess HBV DNA levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
GSK3228836 300 mg
n=11 Participants
Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) administered subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).
|
|---|---|
|
Mean Change From Baseline in HBV DNA at Indicated Time Points
Treatment Day 78
|
-0.271 Log10 IU/mL
Standard Deviation 1.1145
|
|
Mean Change From Baseline in HBV DNA at Indicated Time Points
Off Treatment Day 162
|
-0.237 Log10 IU/mL
Standard Deviation 0.7871
|
SECONDARY outcome
Timeframe: Baseline (Week -1) and off treatment Days 1 and 162Population: Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected from participants at indicated time points to assess anti-HBsAg levels.
Outcome measures
| Measure |
GSK3228836 300 mg
n=12 Participants
Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) administered subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).
|
|---|---|
|
Actual Values of HB Surface Antibody (Anti-HBsAg) Levels at Indicated Time Points
Baseline (Week -1)
|
0.60 Log10 IU/mL
Standard Deviation 0.000
|
|
Actual Values of HB Surface Antibody (Anti-HBsAg) Levels at Indicated Time Points
Off Treatment Day 1
|
0.71 Log10 IU/mL
Standard Deviation 0.238
|
|
Actual Values of HB Surface Antibody (Anti-HBsAg) Levels at Indicated Time Points
Off Treatment Day 162
|
0.70 Log10 IU/mL
Standard Deviation 0.260
|
SECONDARY outcome
Timeframe: Study Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 20, 24, 28, 32 and 36Population: Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected from participants to assess AUC for ALT. On-treatment blood samples were collected from Weeks 1 to 12 and follow-up blood samples were collected from Weeks 12 to 36. AUC was calculated and presented for on-treatment (12 Weeks), follow-up (24 weeks), and On-treatment + follow-up (Weeks 1 to 36).
Outcome measures
| Measure |
GSK3228836 300 mg
n=12 Participants
Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) administered subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).
|
|---|---|
|
Area Under the Concentration-time Curve (AUC) for ALT at Indicated Time Points
On-Treatment (12 Weeks)
|
494.75 Weeks*International Units Per Liter
Standard Deviation 562.593
|
|
Area Under the Concentration-time Curve (AUC) for ALT at Indicated Time Points
Follow-up (24 weeks)
|
650.58 Weeks*International Units Per Liter
Standard Deviation 462.762
|
|
Area Under the Concentration-time Curve (AUC) for ALT at Indicated Time Points
On-Treatment + Follow-Up (Weeks 1 to 36)
|
1173.72 Weeks*International Units Per Liter
Standard Deviation 836.768
|
SECONDARY outcome
Timeframe: Up to Study Week 36Population: Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment.
Time to maximum ALT (maximum peak in ALT) during 36 week (treatment + follow-up) is defined as time from Baseline to the time of first peak in ALT.
Outcome measures
| Measure |
GSK3228836 300 mg
n=12 Participants
Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) administered subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).
|
|---|---|
|
Time to Maximum ALT
|
NA Weeks
Interval 27.1 to
NA indicates median and 95% CI (upper limit) could not be derived, as \<50% of participants experienced the event within the treatment arm.
|
Adverse Events
GSK3228836 300 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GSK3228836 300 mg
n=12 participants at risk
Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) administered subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).
|
|---|---|
|
General disorders
Injection site erythema
|
58.3%
7/12 • Number of events 30 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Injection site pruritus
|
33.3%
4/12 • Number of events 18 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
16.7%
2/12 • Number of events 2 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Injection site bruising
|
16.7%
2/12 • Number of events 10 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Injection site pain
|
16.7%
2/12 • Number of events 40 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
16.7%
2/12 • Number of events 2 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Chest discomfort
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Injection site discomfort
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Injection site swelling
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
25.0%
3/12 • Number of events 3 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
2/12 • Number of events 2 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • Number of events 2 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Number of events 2 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Sensory disturbance
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Diplopia
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Immune system disorders
Seasonal allergy
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
COVID-19
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Respiratory tract infection viral
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Rhinitis
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Creatinine renal clearance decreased
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Platelet count decreased
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
SARS-CoV-2 test positive
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • Number of events 2 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.3%
1/12 • Number of events 1 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • Number of events 2 • Up to Study Week 36
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER